Z-0286-2024 Class I Ongoing
FDA device recall Z-0286-2024 was initiated by Cordis US Corp on September 26, 2023 and is designated Class I. Reason for recall: Non-sterile product labeled as sterile was distributed. The recall status is ongoing. Affected quantity: 30 devices.
Recall Details
- Product Type
- Devices
- Report Date
- November 15, 2023
- Initiation Date
- September 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 devices
Product Description
Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Reason for Recall
Non-sterile product labeled as sterile was distributed.
Distribution Pattern
US Distribution to: OK
Code Information
UDI/DI 10705032025935, Lot Number 18223410